Date: Wednesday, November 11th, 2009 11:00am EST / 4:00pm GMT
It’s not surprising that in today’s economy, companies are actively cutting costs and looking to improve efficiency. Nowhere is that more true than in the emerging biotech industry. Emerging biotech have the need to do more with less while still being competitive with their larger competitors. For some of these companies the thought of investing in a necessary Electronic Document Management System (EDMS) is both overwhelming as well as financially concerning. Fears of the amount of investment both in resources and financially can often lead companies to risk compliance and reduced efficiency.
Featured Speaker: Patricia Santos- Serrão
Patrícia Santos-Serrão is Manager, Global Regulatory Solutions at QUMAS with focus on Clinical and Regulatory Affairs processes. She has been in the Life Sciences industry since 1994 starting her career at Schering-Plough in Kenilworth, NJ, and later joining Boehringer Ingelheim Pharmaceutical in Ridgefield, CT, both in RA. Having had experience with global submissions both paper and electronic over eight years, Santos-Serrão moved into the solutions provider sector joining CDC Solutions, which was later acquired by Liquent, and CSC as a Business Process Specialist and Regulatory Specialist. She has assisted various customers during her time at CDC Solutions, Liquent and CSC in compiling eCTDs, and other submission format filings worldwide.
This session will discuss:
- The business challenges that the biotech industry is facing with regulatory and compliance requirements
- Industry best practice configurations of an EDMS for the biotech industry
- The functionality needed in an EDMS that can help your organization to not only be compliant but more efficient